Oricula Therapeutics Product History

Oricula Therapeutics' first product (ORC-13661), a medicine to preserve hearing during aminoglycoside therapy, has completed preclinical development and has been approved to move into early human testing. It is currently being tested in normal healthy volunteers for safety, tolerability and pharmacokinetics.

Current status

ORC-13661 is a new chemical entity discovered and patented (US 9416141 and US 9493482 ) by University of Washington with grant assistance from NIH, and is exclusively licensed to Oricula Therapeutics LLC. 

Preclinical testing of ORC-13661 has demonstrated hearing protection in animals treated with high doses of the aminoglycoside antibiotic, amikacin. Importantly, it exhibited no interference of the bactericidal effects of aminoglycosides against pathogenic bacteria. Pharmacokinetic studies revealed high oral bioavailability, linear pharmacokinetics over a wide range of doses, and a half-life which supports once-a-day oral therapy. ORC-13661 completed GLP toxicology studies to support the ongoing clinical program.  

An Investigation New Drug (IND) application was approved by the FDA, and a trial of ORC-13661 in normal healthy volunteers was initiated in May of 2018.

Evolution of Oricula

Oricula Therapeutics evolved from converging research into hearing loss and compounds that have potential to prevent it. Results of this research identified compounds that protect inner ear hair cells from ototoxins, specifically aminoglycoside antibiotics. This research and its resulting patents created the foundation for Oricula Therapeutics.

Key company and product milestones:

  • 2003: Novel screening method using zebrafish developed at University of Washington

  • 2008: Research using the aminoglycosides class of antibiotics (AGs) as ototoxins leads to identification of a compound (ORC-0001) that protects hair cells in zebrafish and subsequently protection in rats

  • 2011: NINDS Blueprint Neurotherapeutics Program (NIH BPN) Research Grant awarded; drug discovery and pharmaceutical industry expertise added to team

  • 2012: Method of Use Patent awarded to University of Washington for protectant compound ORC-0001

  • 2012: Structured Activity Relationship (SAR) and ADME research identifies analogs to ORC-0001 that are order-of-magnitude more potent.  

  • 2013:Composition of Matter Patent for ORC-0001 analogs applied for by University of Washington

  • 2013: Oricula Therapeutics LLC founded

  • 2013: Patents for Method of Use and Composition of Matter exclusively licensed from University of Washington by Oricula Therapeutics

  • 2013: Washington State Life Sciences Development Fund awards University of Washington grant to fund efficacy testing of BPN analogs; studies in rats demonstrates mammalian efficacy of ORC-13661

  • 2014: Oricula Therapeutics awarded a Phase 1 SBIR by NIH NIDCD to study safety of ORC-13661

  • 2016: Composition of Matter Patent for ORC-0001 analogs awarded to University of Washington

  • 2016: Oricula Therapeutics awarded a Phase 2 SBIR by NIH NIAID to advance ORC-13661 to FDA-IND

  • 2018: FDA allowed ORC-13661 to move into human clinical trials

  • 2018: Phase 1 clinical trial initiated, testing the pharmacokinetics and safety of ORC-13661 in normal healthy volunteers

  • 2018: Decibel Therapeutics and Oricula Therapeutics Announce Exclusive Licenses for ORC-13661 development for hearing and balance protections. ORC-13661 is now also known as DB-041.